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Only one third pharma companies FMD-compliant six months away from implementation deadline

By Léa Legraien

14 Aug 2018

Only one third of pharmaceutical companies are compliant with Europan anti-counterfeiting measures, according to a representative group.

In a letter sent last week (6 August), the European Medicines Verification Organisation (EMVO) said that of the 2,291 pharmaceutical companies that have to connect to the European Medicines Verification System (EMVS) in less than six months, only 841 (36%) have signed the required agreement. 

The EMVO was set up to implement the Falsified Medicine Directive (FMD), which will come into force on 9 February 2019 in the UK as mandated by the European Commission (EU), to tackle counterfeit medicines and improve patient safety.

Under the directive, all packs of prescription drugs will have to bear a two-dimensional barcode with a unique serial number and anti-tamper device as a means to tackle counterfeit medicines and enhance patient safety. Pharmacists will have to scan each pack of medication before it is dispensed.  


Connecting to the online hub connecting FMD stakeholders is known as ‘on-boarding’.


‘Compliance risk’


The letter said: ‘In January 2018, EMVO announced that the very last opportunity to on-board [in a] timely [manner] was June 2018.

‘Any on-boarding after that date may entail a risk to the company’s compliance with the FMD and consequently to the business too.

‘The on-boarding process can take up to six months to be fully completed by an on-business partner (OBP).

‘EMVO currently counts 841 OBPs that have signed the participation agreement. Four-hundred-and-fifty-three of them reached the technical on-boarding and only 106 of them are connected to the production environment of the EU Hub now.’


‘Bottleneck situation’


Last year, the EMVO encouraged pharmaceutical companies to set up their connection with the EU hub early to avoid ‘bottleneck situations’, which could cause ‘significant increase in on-boarding connection and support costs’, it said.

The letter said: The technical on-boarding – [which includes the choice of the pharmaceutical company’s OBP] is a challenging step in the whole on-boarding process and means that the OBPs have to connect their IT System to the EU Hub.’

The OBP is an entity responsible for managing the upload of data and information about the market authorisation holders’ licensed products into the EMVS via the EU hub, the EMVO said.

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